Status of documentation grading and completeness score for Indian individual case safety reports

The quality of individual case safety reports (ICSRs) generated under Pharmacovigilance Programme of India (PvPI) plays a pivotal role in detecting a signal from Indian drug safety data. Currently, more than hundred thousand ICSRs were generated under PvPI and reported to Uppsala Monitoring Centre....

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Autores principales: Vivekanandan, Kalaiselvan, Rishi, Kumar, Prasad, Thota, Arunabh, Tripathi, Singh, G. N.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Medknow Publications & Media Pvt Ltd 2015
Materias:
Short Communication
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4450561/
https://www.ncbi.nlm.nih.gov/pubmed/26069373
http://dx.doi.org/10.4103/0253-7613.157133
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author Vivekanandan, Kalaiselvan
Rishi, Kumar
Prasad, Thota
Arunabh, Tripathi
Singh, G. N.
author_facet Vivekanandan, Kalaiselvan
Rishi, Kumar
Prasad, Thota
Arunabh, Tripathi
Singh, G. N.
author_sort Vivekanandan, Kalaiselvan
collection PubMed
description The quality of individual case safety reports (ICSRs) generated under Pharmacovigilance Programme of India (PvPI) plays a pivotal role in detecting a signal from Indian drug safety data. Currently, more than hundred thousand ICSRs were generated under PvPI and reported to Uppsala Monitoring Centre. The documentation grading and completeness score of Indian ICSRs were rapidly increasing, and the current score was 0.94 out of 1.0. Periodical training on emphasizing the quality ICSRs is need of the hour.
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spelling pubmed-44505612015-06-11 Status of documentation grading and completeness score for Indian individual case safety reports Vivekanandan, Kalaiselvan Rishi, Kumar Prasad, Thota Arunabh, Tripathi Singh, G. N. Indian J Pharmacol Short Communication The quality of individual case safety reports (ICSRs) generated under Pharmacovigilance Programme of India (PvPI) plays a pivotal role in detecting a signal from Indian drug safety data. Currently, more than hundred thousand ICSRs were generated under PvPI and reported to Uppsala Monitoring Centre. The documentation grading and completeness score of Indian ICSRs were rapidly increasing, and the current score was 0.94 out of 1.0. Periodical training on emphasizing the quality ICSRs is need of the hour. Medknow Publications & Media Pvt Ltd 2015 /pmc/articles/PMC4450561/ /pubmed/26069373 http://dx.doi.org/10.4103/0253-7613.157133 Text en Copyright: © Indian Journal of Pharmacology http://creativecommons.org/licenses/by-nc-sa/3.0 This is an open-access article distributed under the terms of the Creative Commons Attribution-Noncommercial-Share Alike 3.0 Unported, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Short Communication
Vivekanandan, Kalaiselvan
Rishi, Kumar
Prasad, Thota
Arunabh, Tripathi
Singh, G. N.
Status of documentation grading and completeness score for Indian individual case safety reports
title Status of documentation grading and completeness score for Indian individual case safety reports
title_full Status of documentation grading and completeness score for Indian individual case safety reports
title_fullStr Status of documentation grading and completeness score for Indian individual case safety reports
title_full_unstemmed Status of documentation grading and completeness score for Indian individual case safety reports
title_short Status of documentation grading and completeness score for Indian individual case safety reports
title_sort status of documentation grading and completeness score for indian individual case safety reports
topic Short Communication
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4450561/
https://www.ncbi.nlm.nih.gov/pubmed/26069373
http://dx.doi.org/10.4103/0253-7613.157133
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